AccessGUDID - DEVICE: Zutron Medical (00817658023806)

GUDID

Device Identifier (DI) Information

Brand Name: Zutron Medical
Version or Model: Endo Leak Tester
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZUTR10005CA
Company Name: ZUTRON MEDICAL, L.L.C.

Primary DI Number: 00817658023806
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 962532441 *Terms of Use

Device Description: Calibration Adapter Endo-Leak Tester

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37006	Invasive medical device leak tester, electrical	An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCY	Bulb, Inflation, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5afa2dc-1d1e-46b8-a709-1b1833fc6218
Public Version Date: June 10, 2025
Public Version Number: 2
DI Record Publish Date: September 21, 2023